Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the persistence of bactericidal antibodies in adolescents and adults who received one dose of Menactra® vaccine approximately four to eight years earlier
Subjects who received one dose of Menactra® or Menomune® in study MTA04, MTA12, MTA19 (NCT00777790), or MTA21 (NCT00777257) will be eligible for enrollment in trial this study. All eligible subjects will provide a blood sample at Visit 1, after which their participation in the study will be terminated. An age-matched meningococcal-vaccine naïve control group will be recruited to provide a blood sample for baseline antibody level evaluation.
No vaccine will be administered in this study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Menactra® from Previous Studies | Subjects previously received only one dose of meningococcal vaccine, Menactra® in Study MTA04, MTA12, MTA19, or MTA21. |
| |
| Group 2: Menomune® from Previous Study | Subjects previously received only one dose of meningococcal vaccine, Menomune® in Study MTA04 |
| |
| Group 3: Control | Meningococcal vaccine-naive age matched subjects |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Menactra® | Biological | 0.5 mL, Intramuscular (from a previous study) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment | Day 0 | |
| Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment | Day 0 |
Not provided
Not provided
Inclusion Criteria :
Exclusion Criteria :
Not provided
Not provided
Subjects that previously received only one dose of meningococcal vaccine, Menactra® in Study MTA04, MTA12, MTA19 (NCT00777790), or MTA21 (NCT00777257); or Menomune® in Study MTA04 and age-matched meningococcal vaccine-naive controls.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | 72205 | United States | |||
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
A total of 763 participants who met the inclusion and exclusion criteria were enrolled. One participant withdrew before sampling and is excluded from analysis and this report.
Participants were enrolled from 16 December 2008 to 16 March 2009 in 21 medical centers in the US.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Menactra® From Previous Studies | Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21 |
| FG001 | Group 2: Menomune® From Previous Study |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Menomune® | Biological | 0.5 mL, Intramuscular (from a previous study) |
|
| Fountain Valley |
| California |
| 92708 |
| United States |
| Marietta | Georgia | 30062 | United States |
| Martinez | Georgia | 30907 | United States |
| Woodstock | Georgia | 30189 | United States |
| Bardstown | Kentucky | 40004 | United States |
| Omaha | Nebraska | 68131 | United States |
| Austintown | Ohio | 44515 | United States |
| Cleveland | Ohio | 44121 | United States |
| Erie | Pennsylvania | 16505 | United States |
| Greenville | Pennsylvania | 16125 | United States |
| Harleysville | Pennsylvania | 19438 | United States |
| Latrobe | Pennsylvania | 15650 | United States |
| Pittsburgh | Pennsylvania | 15236 | United States |
| Pittsburgh | Pennsylvania | 15241 | United States |
| Sellersville | Pennsylvania | 18960 | United States |
| Wexford | Pennsylvania | 15090 | United States |
| Kingsport | Tennessee | 37660 | United States |
| Spokane | Washington | 99202 | United States |
| Spokane | Washington | 99218 | United States |
Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
| FG002 | Group 3: Control | Meningococcal vaccine-naive, age-matched participants |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Menactra® From Previous Studies | Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21 |
| BG001 | Group 2: Menomune® From Previous Study | Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04 |
| BG002 | Group 3: Control | Meningococcal vaccine-naive, age-matched participants |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment | Serum Bactericidal Assay Baby Rabbit Complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population. | Posted | Number | Percentage of Participants | Day 0 |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment | Serum Bactericidal Assay Baby Rabbit Complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 0 |
|
|
There were no safety outcomes; safety data were not collected in this study.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: Menactra® From Previous Studies | Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21 | 0 | 0 | 0 | 0 | ||
| EG001 | Group 2: Menomune® From Previous Study | Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04 | 0 | 0 | 0 | 0 | ||
| EG002 | Group 3: Control | Meningococcal vaccine-naive, age-matched participants | 0 | 0 | 0 | 0 |
Not provided
Not provided
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | RegistryContactUs@sanofipasteur.com |
| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| D008581 | Meningitis |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D022401 | Meningococcal Vaccines |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
|
| Serogroup C ≥ 8 [n = 557, 92, 99] |
|
| Serogroup C ≥ 128 [n = 557, 92, 99] |
|
| Serogroup Y ≥ 8 [n = 558, 93, 99] |
|
| Serogroup Y ≥ 128 [n = 558, 93, 99] |
|
| Serogroup W-135 ≥ 8 [n = 556, 92, 99] |
|
| Serogroup W-135 ≥128 [n = 556, 92, 99] |
|
|